FDA Approves NRx’s Preservative-Free Generic Ketamine, While Its Petition to Remove Rivals’ BZT Products Remains Pending

NRx Pharmaceuticals has received FDA approval for KETAFREE, a preservative-free generic ketamine product approved through the Abbreviated New Drug Application pathway. Because it carries the same label as Ketalar, the first FDA-approved ketamine product, KETAFREE is currently on-label only for anesthesia. Its key difference is the absence of benzethonium chloride, or BZT, an antimicrobial preservative used in some multidose ketamine products. The approval completes the first part of NRx’s strategy to compete with existing generic suppliers. Its separate citizen petition asking the FDA to remove BZT-containing ketamine products from the market remains under agency review. NRx is also pursuing NRX-100, an investigational preservative-free IV ketamine formulation intended for on-label treatment of depression and suicidality, using existing clinical, regulatory, and real-world data.